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Gray

Active Ingredient:
Levofloxacin Hemihydrate
Origin:
EU

Gray (Levofloxacin Hemihydrate)

Gray is an oral tablet containing levofloxacin hemihydrate, a fluoroquinolone antibiotic, marketed in the European Union. The product’s strength is not specified in the available data, and it is supplied as a prescription‑only medication. Levofloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, which blocks DNA replication and transcription in susceptible bacteria. It is intended for systemic treatment of a range of bacterial infections as determined by a healthcare professional.

Manufacturer / TM Owner

Aurora Biofarma S.R.L

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Indications & Clinical Uses

Gray is prescribed for the treatment of several common bacterial infections where levofloxacin is appropriate.

  • Community‑acquired pneumonia
  • Acute bacterial sinusitis
  • Uncomplicated urinary tract infection
  • Acute exacerbation of chronic bronchitis
  • Skin and soft‑tissue infections

Side Effects

Levofloxacin may cause a range of adverse effects, most of which are mild and reversible.

Common

  • Nausea or vomiting
  • Diarrhea
  • Headache
  • Dizziness
  • Rash

Serious

  • Tendon rupture or inflammation
  • Peripheral neuropathy
  • Severe allergic reactions such as anaphylaxis or Stevens‑Johnson syndrome
  • QT interval prolongation
  • Clostridioides difficile‑associated diarrhea

Precautions & Warnings

Before prescribing Gray, clinicians should evaluate patient‑specific factors and potential risks associated with fluoroquinolone therapy.

  • Known hypersensitivity to levofloxacin or other fluoroquinolones
  • History of tendon disorders or recent corticosteroid use
  • Renal impairment requiring dose adjustment
  • Pregnancy or breastfeeding status (safety not established)
  • Concomitant use of drugs that prolong QT interval
  • Patients with myasthenia gravis (may exacerbate symptoms)

Avoid Interactions

Levofloxacin can interact with other medicines, affecting efficacy or safety.

Avoid

  • Antacids containing aluminum or magnesium, or iron supplements (reduce absorption)
  • Warfarin (increased anticoagulant effect)
  • Non‑steroidal anti‑inflammatory drugs (risk of CNS stimulation)

Use with caution

  • Theophylline (possible increased levels)
  • Cyclosporine or tacrolimus (monitor concentrations)
  • Diabetic agents (may affect blood glucose)

Frequently Asked Questions

Gray is a prescription‑only oral tablet that contains the fluoroquinolone antibiotic levofloxacin hemihydrate.

Gray is indicated for community‑acquired pneumonia, acute bacterial sinusitis, uncomplicated urinary tract infections, acute exacerbations of chronic bronchitis, and skin or soft‑tissue infections.

Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for DNA replication and transcription, leading to bacterial cell death.

The safety of levofloxacin in pregnancy has not been established; it should be used only if the potential benefit justifies the potential risk to the fetus.

Common adverse effects include nausea, vomiting, diarrhea, headache, dizziness, and skin rash.

Serious reactions may include tendon rupture, peripheral neuropathy, severe allergic responses such as anaphylaxis or Stevens‑Johnson syndrome, QT prolongation, and Clostridioides difficile‑associated colitis.

Yes, patients with previous tendon disorders or those taking corticosteroids are at higher risk for tendon injury and should generally avoid fluoroquinolones like Gray.

Antacids containing aluminum, magnesium, or iron can reduce levofloxacin absorption and should be taken at least two hours apart from Gray.

Levofloxacin can increase the anticoagulant effect of warfarin, so more frequent monitoring of INR is recommended when the drugs are co‑administered.

Clinicians may monitor renal function, signs of tendon pain, QT interval on ECG, and for any signs of severe allergic reactions during therapy.

Levofloxacin is primarily excreted by the kidneys; dose adjustment may be required in patients with reduced renal function.

Levofloxacin is generally not recommended for routine use in children unless no alternative antibiotic is available and the benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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